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DONJOY 11-1422Recalls & reported problems

Djo, LLC · ICEMAN W/,UNIV,LOOP,NS,RH · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912005869), received between May 5, 2021 and May 5, 2021 — classified as 1 injury.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Mar 19, 2026Open, Classified

    Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

    Z-2135-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Unspecified Tissue Injury1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY THE HOSPITAL STAFF THAT A COLD THERAPY MACHINE (ICEMAN CLASSIC CUBE) ALLEGEDLY CAUSED TISSUE DAMAGE AFTER THE PATIENT HAD THE UNIT FOR 2 DAYS.

    Patient problems: Unspecified Tissue Injury

    MAUDE report 11780300 ↗

Other Pack, hot or cold, water circulating devices

All Pack, hot or cold, water circulating devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.